Informed consent is the process of obtaining permission of a subject for participation in studies and has an opportunity to decide about his or her healthcare. This notion originates from the legal and ethical right of the patient/subject to retain autonomy and from the ethical duty of the physician/researcher to involve the patient in healthcare decisions. Informed consent also implies that a dialog has taken place about the nature of the decision, reasonable alternatives, relevant risks, benefits and uncertainties of the decision, and the comprehension and acceptance of the healthcare decision by the patient/subject.
To properly assess informed consent, the investigator or the coordinator of the research conducts the consent process and presents the study with elements pertaining to the consent. These elements of informed consent include: statement explaining the purpose of the research; the procedures involved and the duration of the study; description of foreseeable risks; description of benefits; disclosure of alternative treatments or procedures; explanation of compensation; list of contacts to help with questions; and a statement that participation is voluntary.
Responsibilities of the principal Investigator
Although the patient agrees to participate in the study by signing the consent, informed consent does not absolve the physician/researchers from their responsibility to conduct safe and ethically sound practices. Informed consent also retains the patients’ right to file a lawsuit against the physician or researchers if wrong doing is suspected. The other responsibilities of the principal investigator include conducting the study in accordance to the approved protocol, maintaining adequate and accurate records.
Voluntary informed consent is the cornerstone of federal policies regulating clinical trials. However, there are situations where a written informed consent is difficult to attain. Such is the case in a critically ill or injured patient who is unconscious or incompetent. Consequently, investigational treatment may be required immediately to resuscitate the patient under a life-threatening situation. However, without the informed consent, the potential life saving experimental therapy cannot be instituted.
When informed consent is not necessary
Informed consent is not required for research involving no more than minimal risk. Minimal risk is defined as risk that is comparable to those encountered in daily life. Informed consent is also not required in studies where the consent process may adversely impact the findings by disclosing too much information and creating a bias. As in the case of Final rule, if informed consent is waived in favour of initiating emergency treatment, consent can be deferred until later in the course of the study. This consent can be granted by the patient or his or her representative.